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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

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The European Medicines Agency (EMA) will for the first time begin publishing public assessment reports (PARs) for pharmaceutical and biological medicines used in medical devices, the agency said in an 8 August announcement.

The EU regulatory agency does not, to the consternation of critics, review medical devices. Devices intended for marketing in Europe are instead regulated through the European Conformity (CE) marking system, through which devices are assessed by either the manufacturer or a Notified Body before being allowed on the market.

EMA officials said despite this, the presence of the ancillary medicinal substances in the device places the substance-and the substance alone-under their purview, requiring them to provide a scientific opinion on the substance to the Notified Body. The opinion, "Addresses the quality and safety of the medicinal substances including the clinical benefit/risk profile of the incorporation of the substance into the device," EMA explained.

The agency has already given nine such opinions since 2005, it said in a statement, but until now they had remained unpublished. All future PARs for devices containing ancillary substances will be made publicly available, EMA wrote.